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K Number
K202299
Device Name
Ultrasonic Surgical Aspirator System
Manufacturer
SMTP Technology Co., Ltd
Date Cleared
2021-05-21

(281 days)

Product Code
LFL
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K172464,K070313,K062471
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

  • · Neurosurgery
  • · Gastrointestinal and Affiliated Organ Surgery
  • · Urological surgery
  • · Plastic and Reconstructive surgery
  • · General Surgery
  • · Orthopedic Surgery
  • · Gynecological Surgery
  • · Thoracic Surgery
  • · Wound Care
  • · Laparoscopic Surgery
  • · Thoracoscopic Surgery
Device Description

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissue, and can also be used for precise cutting, crushing and shaping of bone tissue. The product can be applied to a number of departments by using the suitable parameters and accessories, including:

  • . Department of Neurosurgery, general surgery and other departments for soft tissue cutting, breakage and aspiration.
  • . Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
  • . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
    The XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.
AI/ML Overview

This document describes the FDA 510(k) clearance for the Ultrasonic Surgical Aspirator System (XD880B), focusing on its substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria.

Therefore, the specific information requested, such as a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone algorithm performance, is not present or applicable in the provided document.

The document details the device's technical specifications and non-clinical performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance:

  • Not applicable in the context of this document. This document focuses on demonstrating substantial equivalence based on technical characteristics and non-clinical testing, not on achieving specific clinical performance metrics against predefined acceptance criteria from a clinical trial.
  • The "performance" described is in terms of passing various non-clinical standard tests (e.g., electrical safety, EMC, software verification, sterilization validation, shelf-life, lifetime validation, acoustic performance, efficiency and temperature characteristics).

2. Sample sizes used for the test set and the data provenance:

  • Not applicable. This submission relies on non-clinical testing and comparison to predicate devices, not on a clinical test set in the way a diagnostic AI would.
  • The document implies that various units of the device and its components were tested to meet the specified non-clinical standards, but explicit "sample sizes" for a clinical test set are not mentioned as no clinical performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. No clinical ground truth establishment involving human experts is described. The "truth" for this submission is based on engineering standards and technical specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not applicable. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • No. A MRMC study was not conducted as this is an ultrasonic surgical aspirator system, not a diagnostic AI system designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

  • Not applicable. This device is a surgical tool, not a standalone diagnostic algorithm. Its function inherently involves human operation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

  • Technical Specifications and Standard Compliance: The "ground truth" for this submission is adherence to engineering specifications and compliance with international and national standards for medical devices (e.g., IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, IEC 62304 for software, ISO 17665-1 and ISO 11135 for sterilization). The device's performance is measured against these established technical benchmarks.

8. The sample size for the training set:

  • Not applicable. This is a hardware medical device, not an AI/ML model that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established:

  • Not applicable. See point 8.

Summary of Device Acceptance (from the document's perspective):

The acceptance mechanism for this device's FDA clearance is "Substantial Equivalence" to legally marketed predicate devices. This is achieved by demonstrating that the new device:

  • Has the same intended use.
  • Has the same or similar indications for use.
  • Has the same or similar technological characteristics.
  • Does not raise new or different questions of safety or effectiveness.

Studies/Data that Proved Device Meets "Acceptance Criteria" (i.e., Substantial Equivalence):

The document states that the following non-clinical tests were conducted and passed to support substantial equivalence:

  • Electrical safety testing per IEC 60601-1
  • EMC testing per IEC 60601-1-2
  • Software verification and validation per IEC 62304 / FDA Guidance
  • Moist heat sterilization validation per ISO 17665-1
  • EO sterilization validation per ISO 11135 (demonstrates SAL of 10^-6)
  • Shelf-life Testing
  • Lifetime validation test for handpieces
  • Acoustic Performance Test per IEC 61847
  • Efficiency and Temperature Characteristics Test

These tests confirm that the device's design inputs and performance specifications are met, allowing the FDA to determine that it is as safe and effective as the predicate devices, thereby meeting the "acceptance criteria" for 510(k) clearance by way of substantial equivalence.

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